A Prospective, Randomized, Self-Controlled 14 day Clinical Study to evaluate the anti-aging effect of topical application of Tanusha- Ayurvedic polyherbal Formulation for Rejuvenation of facial skin.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To assess the effect of 14 day application of Tanusha Ayurvedic formulation in facial skin repair and rejuvenation
研究概览
简要总结
A clincial trial is to be conducted to assess the effect of 14 day Clinical Study to Evaluate theEfficacy of Ayurvedic polyherbal formulation Tanusha as a paraben-free &poly-ethylene bead-free exfoliating anti-aging strategy for improving theappearance of facial skin is proposed. Total number of patients is 30 and as it is a single arm trial, all patients will be administered the same intervetion. 1 g ofTanusha to be mixed with ordinary water and form paste for topical applicationon facial skin. The data gathered from patient assessment on Day 0, Day 7 and Day 14 is to be assessed and analyzed and the results and discussions are to be recorded. This study will beconducted in compliance with the protocol approved by the IEC. No deviationfrom the protocol will be implemented without the prior review and approval ofthe IEC except where it may be necessary to eliminate an immediate hazard to aresearch subject. In such case, the deviation will be reported to the IEC assoon as possible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Any male or female adults between 18-60 years 2.Subject who is willing to give informed consent and is able to comply with all trial requirements.
- •3.Subjects with all skin types 4.Subjects who have sensitive and acne prone skin.
- •5.Subjects who have hyper pigmentation problems with skin irritation.
排除标准
- •1.Subjects with chronic diseases like severe liver, renal, cardiac or brain diseases.
- •2.Pregnant or lactating women 3.Subjects that are Allergic to any medication 4.With a history of alcohol and/or drug abuse.
结局指标
主要结局
To assess the effect of 14 day application of Tanusha Ayurvedic formulation in facial skin repair and rejuvenation
时间窗: Day 0, Day 7 and Day 14
次要结局
- To assess its efficacy in removing marks and acne.(Day 0, Day 7 and Day 14)